Contralaterally Controlled FES for Chronic Arm/Hand Hemiplegia: Single-Site RCT

描述（由申请人提供）：上肢偏瘫是中风导致的最严重和最常见的损伤之一。在美国每年发生的超过75万例中风中，大约75%会导致某种程度的上肢瘫痪。大约65%的中风幸存者在中风6个月后仍不能使用受影响的手辅助日常生活活动。上肢损伤对残疾和健康的影响很大，但旨在恢复上肢损伤功能的康复干预措施相对较少。因此，我们的长期目标是开发上肢康复疗法，有效地恢复手臂和手的功能，适用于各种严重程度的损伤，并易于在当前的医疗环境中实施。本研究的目的是评估对侧控制功能电刺激（CCFES）在减轻慢性上肢偏瘫患者上肢损伤和活动限制方面的疗效。CCFES是一种神经肌肉电刺激（NMES）应用于麻痹上肢的手指和拇指伸肌来打开手的康复干预。中风幸存者通过调节对侧未受损手的张开程度来控制刺激强度和随后的手张开程度，这是由仪器手套检测到的。因此，未受影响的手的意志打开产生受影响的手的刺激打开。刺激模式是用来帮助中风幸存者练习功能任务与他们的影响手。CCFES在慢性偏瘫中的初步研究令人鼓舞。该项目将扩展已经开始的工作：1)确定12周CCFES是否对慢性中风幸存者有效，2)确定12周完成前治疗效果是否达到平台期，3)确定初始运动损伤水平如何影响治疗效果，以及4)确定治疗效果是否持续。我们将进行一项随机对照试验，其中102名慢性中风幸存者（中风后6个月）将被随机分配接受12周的CCFES或循环NMES，这是一种提供手伸肌电刺激的干预，但具有预先设定的时间和强度。随机化将按两个水平的基线手部损伤分层，这两个水平是由手指的自主伸展程度定义的。在治疗期间每3周评估一次上肢损伤和活动限制，在6个月的随访期间每2个月评估一次。本研究是CCFES治疗慢性上肢偏瘫的首个随机对照试验。最终，在这项研究中获得的信息将有助于加速减少中风后残疾的治疗方法的发展。对因中风致残的个人需要有效的康复干预措施。这项研究是开发一种新的治疗方法的重要一步，这种治疗方法可能更有效地促进持久的运动恢复，更广泛地适用于更广泛的中风幸存者，并且比现有的中风康复技术更容易实施。随着更有效的卒中康复疗法的发展，卒中后残疾的患病率可能会下降。

DESCRIPTION (provided by applicant): Hemiparesis of the upper limb is one of the most serious and most common impairments resulting from stroke. Approximately 75% of the over 750,000 strokes that occur annually in the United States cause some degree of upper extremity paralysis. Approximately 65% of stroke survivors still cannot use their affected hand to assist with activities of daily living 6 months after their stroke. The impact of upper extremity impairments on disability and health is great, yet there are relatively few rehabilitation interventions designed to restore function to the impaired upper limb. Therefore, our long-term objective is to develop upper extremity rehabilitation therapies that are effective at restoring arm and hand function, that are applicable across a wide range of impairment severity, and that are readily implemented in the present healthcare environment. The purpose of this study is to estimate the efficacy of Contralataterally Controlled Functional Electrical Stimulation (CCFES) in reducing upper extremity impairment and activity limitation in chronic upper extremity hemiplegia. CCFES is a rehabilitation intervention in which neuromuscular electrical stimulation (NMES) is applied to the finger and thumb extensor muscles of the paretic upper limb to open the hand. The stroke survivor controls the stimulation intensity, and consequent degree of hand opening, by modulating the degree of opening of the contralateral unimpaired hand, which is detected by an instrumented glove. Thus, volitional opening of the unaffected hand produces stimulated opening of the affected hand. The stimulation paradigm is used to assist the stroke survivor in practicing functional tasks with their affected hand. Pilot studies of CCFES in chronic hemiplegia were encouraging. This project will expand on the work already begun by: 1) determining if 12 weeks of CCFES is therapeutically effective in chronic stroke survivors, 2) determining if a plateau in treatment effect is achieved before 12 weeks is completed, 3) determining how initial level of motor impairment affects treatment efficacy, and 4) determining whether therapeutic gains persist over time. We will conduct a randomized controlled trial in which 102 chronic stroke survivors (>6 months post-stroke) will be randomly assigned to receive 12 weeks of CCFES or cyclic NMES, an intervention that provides electrical stimulation of the hand extensors, but with preprogrammed timing and intensity. Randomization will be stratified on two levels of baseline hand impairment defined by the degree of voluntary finger extension present. Assessments of upper extremity impairment and activity limitation will be made every 3 weeks during the treatment period and every 2 months during a 6-month follow-up period. This study is the first randomized controlled trial of CCFES in chronic upper extremity hemiplegia. Ultimately, the information learned in this study will serve to accelerate the development of treatments for reducing post-stroke disability. PUBLIC HEALTH RELEVANCE There is a need for effective rehabilitation interventions for individuals who have become disabled by stroke. This study is an important step toward the development of a new treatment that may be found to be more effective in facilitating lasting motor recovery, more widely applicable to a broader range of stroke survivors, and more readily implemented than existing stroke rehabilitation techniques. As more effective stroke rehabilitation therapies are developed, the prevalence of post-stroke disability may be decreased.